{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Fajardo",
      "address_1": "Calle Igualdad Final #7",
      "reason_for_recall": "Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",
      "address_2": "",
      "product_quantity": "2 lots; 48 units (multiple units per lot)",
      "code_info": "Product code 900-548A,  2 lots:  140312022  140412694",
      "center_classification_date": "20140829",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) in the state of  Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.",
      "state": "PR",
      "product_description": "PERY GYN PACK -    (1) TABLE COVER REINFORCED 44\" X 78\"   (1) DRAPE UTILITY  (2) TOWELS ABSORBENT 15\" X 20\"   (1) GOWN XL SMS IMPERV. REINF. AAMI LEVEL Ill  (1) DRAPE UNDERBUTIOCK W/POUCH 44\" X 35\"   (1) TIME OUT BEACON NON WOVEN  (1) BOWL UTILITY BLUE 16oz   (1) BAG SUTURE FLORAL  (1 0) GAUZE SPONGE 4\" X 4\" 16 PLY XRD   (1) GOWN IMPERV. EXTRA REINF LGE AAMI LEVEL Ill T/WRAP  (1) CATHETER 16\" 18FR MALE PVC   (2) LEGGINS W/7'' CUFF 30\" X 44\"    EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents",
      "report_date": "20140910",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Customed, Inc",
      "recall_number": "Z-2332-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68536",
      "termination_date": "20170814",
      "more_code_info": "",
      "recall_initiation_date": "20140520",
      "postal_code": "00738",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}